Every drug comes with side effects, but patients taking the diabetes drug, Tradjenta, should be aware of a chronic side effect that can be fatal in some cases. The label of Tradjenta already warns users of the possibility of Bullous Pemphigoid, but three recent studies have concluded that this side effect is a huge risk that could warrant discontinued use by high-risk patients.
Tradjenta, also known as lingliptin, is an oral medication that was approved by the Food and Drug Administration (FDA) in 2012. It is used to treat type 2 diabetes. When used in conjunction with diet and exercise, it can help reduce A1C and blood sugar levels. While this drug can be a lifesaver for those who struggle with diabetes, it comes a risk of Bullous Pemphigoid in certain patient populations.
What is Bullous Pemphigoid?
Bullous Pemphigoid is a rare skin condition that causes fluid-filled blisters. It is caused by an abnormal immune response. Trajendta patients who are elderly or who have a pre-existing neurological diagnosis are especially at risk for developing this serious condition.
What are the symptoms of Bullous Pemphigoid?
Patients with this condition suddenly develop erosions or blisters. Bullous Pemphigoid needs to be treated quickly to avoid infection, which can lead to sepsis. Sepsis is a blood infection that is often fatal.
How Do You Treat Bullous Pemphigoid?
Bullous Pemphigoid is usually treated with topical or systemic immunosuppressive treatment. Most patients tended to recover fully. Patients should also be referred to a dermatologist for further medical treatment and evaluation.
After discontinuing use of Tradjenta and treating the
What the Studies Say About Tradjenta Use & Bullous Pemphigoid Risk
Recent studies show that the use of DPP-4 inhibitors – particularly diabetes drugs – contributes to Bullous Pemphigoid. DPP-4 inhibitors drugs include Tradjenta, Glyxambi, Jentadueto and Jentadueto XR which are used to treat diabetes.
Several studies have shown a relationship between Tradjenta use and Bullous Pemphigoid. An August 2018 study included 328 control participants as well as 82 patients with Bullous Pemphigoid. The results showed that use of DPP-4 inhibitors were associated with a three-fold risk increase for developing Bullous Pemphigoid.
A July 2018 Japanese study also highlighted an increased risk among DPP-4 inhibitor use and Bullous Pemphigoid. Researchers identified 546 Bullous Pemphigoid cases from the Japanese Adverse Drug Event Report (JADER) database. After assessing those cases, it was found that 392, or 71%, of those cases were associated with DPP-4 inhibitor use.
A third study, published in June 2018, showed that Bullous Pemphigoid might be drug‐induced. The prevalence of Bullous Pemphigoid in 9,304 patients who had taken DPP-4 inhibitorswas 0.0859%. This percentage is higher than the percentage among those who did not use DPP-4 inhibitors.
In individual studies, those who developed Bullous Pemphigoid did not heal completely until they stopped use of Tradjenta.
What the Tradjenta Label Says About Bullous Pemphigoid Risk
The FDA has not yet updated labeling for Tradjenta and other DPP-4 inhibitor drugs like Glyxambi, Jentadueto and Jentadueto XR. Currently, the Bullous Pemphigoid already lists Bullous Pemphigoid as a potential side effect.
This warning has been in place since December 2016. The label notes that there have been reports of Bullous Pemphigoid diagnoses in Tradjenta users, and that some patients have required hospitalization to treat the condition.
Failure To Adequately Warn Certain High-Risk Patient Populations
We believe that the current Tradjenta labeling and warning is insufficient to warn certain patient populations of the increased risk of developing this serious medical condition. We believe that the label should note the heightened risk for developing this condition among elderly patients and patients with neurological disorders.
Do I Have A Case?
The dangerous drug attorneys at Nadrich & Cohen are actively investigating claims of elderly Tradjenta patients or Tradjenta users who had a pre-existing neurological condition and were subsequently diagnosed with Bullous Pemphigoid while using Tradjenta.
If you or a loved one believe that you may have a claim, please immediately contact our office for a free case evaluation. We want to speak with you and answer all of your questions. Call us today at 1-800-718-4658.